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Crystalloid Therapy

High Calcium Crystalloid Therapy for Cardiac Arrest (SPEAR Trial)

Phase 2 & 3
Recruiting
Led By Carol Bernier, DO
Research Sponsored by Carol Bernier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients who present with PEA at any time during the patients' treatment by Roanoke Fire-EMS, Botetourt County Department of Fire & EMS and/or Salem Fire-EMS. This study defines a PEA presentation as any patient who is unconscious, presenting without a carotid pulse and with non-(VT/VF) ventricular tachycardia/ventricular fibrillation electrical activity.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through resuscitation efforts up to 1 hour after arrival to (ed) emergency department
Awards & highlights

SPEAR Trial Summary

This trial is studying whether a high calcium, low sodium fluid given to patients with pulseless electrical activity (PEA) in pre-hospital care will improve the chances of survival.

Who is the study for?
The SPEAR study is for patients who experience a type of cardiac arrest called PEA, where the heart's electrical activity is normal but it doesn't contract. Participants must be treated by certain EMS providers in Roanoke and not have a DNR order, known pregnancy, untreated cardiac arrest over 30 minutes, traumatic cardiac arrest, LVAD device or digitalis toxicity.Check my eligibility
What is being tested?
This trial tests if High Calcium, Low Sodium (HCLS) fluid improves survival in PEA compared to standard salt solution therapy. It's a double-blind study meaning neither the patient nor provider knows which treatment is given. Patients are randomly assigned to receive either HCLS or routine fluid therapy.See study design
What are the potential side effects?
Since both fluids used in this trial are based on FDA approved components and one is already standard care, side effects may be minimal and similar to those experienced with typical IV fluids such as electrolyte imbalances or reactions at the infusion site.

SPEAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was unconscious and had no pulse but my heart wasn't in a common irregular rhythm.

SPEAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through resuscitation efforts up to 1 hour after arrival to (ed) emergency department
This trial's timeline: 3 weeks for screening, Varies for treatment, and through resuscitation efforts up to 1 hour after arrival to (ed) emergency department for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event Survival
Secondary outcome measures
Any Return-Of-Spontaneous-Circulation (ROSC)
Neurological outcome at hospital discharge
Serum Electrolyte Values
+1 more

SPEAR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-Calcium, Low- Sodium (HCLS) groupExperimental Treatment1 Intervention
Patients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.
Group II: High-Calcium, High- Sodium (HCHS) groupActive Control1 Intervention
Patients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityOTHER
139 Previous Clinical Trials
27,282 Total Patients Enrolled
Carol BernierLead Sponsor
Carol Bernier, DOPrincipal InvestigatorVirginia Polytechnic Institute and State University

Media Library

High Calcium, Low Sodium (HCLS) Crystalloid Therapy (Crystalloid Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05283850 — Phase 2 & 3
Cardiac Arrest Research Study Groups: High-Calcium, High- Sodium (HCHS) group, High-Calcium, Low- Sodium (HCLS) group
Cardiac Arrest Clinical Trial 2023: High Calcium, Low Sodium (HCLS) Crystalloid Therapy Highlights & Side Effects. Trial Name: NCT05283850 — Phase 2 & 3
High Calcium, Low Sodium (HCLS) Crystalloid Therapy (Crystalloid Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283850 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are needed for this research project?

"That is correct. The clinical trial detailed on clinicaltrials.gov is still recruiting patients. The study's 342 participants will be drawn from a single site, and the trial was originally posted on February 16th, 2022."

Answered by AI

Can new participants still join this research project?

"Yes, the clinicaltrials.gov website indicates that this trial is currently recruiting patients. The listing was first posted on February 16th, 2022 and was last updated on March 8th, 2022. The study is looking for 342 participants at 1 location."

Answered by AI
~197 spots leftby Feb 2027